Date:28/09/2005 URL: http://www.thehindubusinessline.com/2005/09/28/stories/2005092802460200.htm

Back Aurobindo gets USFDA nod

Our Bureau

HYDERABAD: Aurobindo Pharma Ltd has obtained a tentative approval from the US Food and Drug Administration (USFDA) for the abbreviated new drug application (ANDA) of Setraline Hydrochloride in tablets of 25 mg (base), 50 mg (base) and 100 mg (base).

In a press release here on Tuesday, the company said it would be able to market the product in the US market after the expiry of the Setraline Hydrochloride product patent and also upon final approval from the USFDA.

Aurobindo Pharma said the tentative approval is important for the company in terms of its R&D capabilities. The approval terms the generic drug product to be bio-equivalent and having the same therapeutic effect to the innovator product - Zoloft of Pfizer Inc - the release said.